Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
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ClinicalTrials.gov Identifier: NCT02280603 |
Recruitment Status :
Completed
First Posted : October 31, 2014
Last Update Posted : June 24, 2015
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This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia
Design : Randomized, double-blind, active-controlled study
Investigational Product : Finasteride, minoxidil
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Androgenetic Alopecia | Drug: DA-4001C Drug: 5% minoxidil | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: DA-4001C
DA-4001C is administered
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Drug: DA-4001C
1ml by topical application twice a day |
Active Comparator: 5% minoxidil
5% minoxidil is administered
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Drug: 5% minoxidil
1ml by topical application twice a day
Other Name: minoxyl |
- Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram [ Time Frame: baseline and week 24 ]
- Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram [ Time Frame: Baseline and week 16 ]
- Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram [ Time Frame: Baseline, week 16,and week24 ]
- Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram [ Time Frame: Baseline, week 16, and week 24 ]

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2
Exclusion Criteria:
- Evidence of hair loss other than androgenetic alopecia
- Use of finasteride, dutasteride within previous 12 months
- Use of minoxidil within previous 6 months
- Use of androgenic or anti-androgenic agents within previous 6 months
- Use of steroid agents for local application to scalp or systemic application within previous 1 month
- History of hair transplantation, scalp reduction
- Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280603
Korea, Republic of | |
Catholic Medical Center | |
Seoul, Dongdaemun-gu, Korea, Republic of, 130-709 |
Principal Investigator: | Hoon Kang, M.D, Ph.D | The catholic univ. of korea, St.Paul's hospital |
Responsible Party: | Dong-A ST Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02280603 |
Other Study ID Numbers: |
DA4001_AGAP_POC |
First Posted: | October 31, 2014 Key Record Dates |
Last Update Posted: | June 24, 2015 |
Last Verified: | June 2015 |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases |
Pathological Conditions, Anatomical Minoxidil Antihypertensive Agents Vasodilator Agents |